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No randomised trials have addressed the value of systematic aortic and pelvic lymphadenectomy (SL) in ovarian cancer macroscopically confined to the pelvis. This study was conducted to investigate the role of SL compared with lymph nodes sampling (CONTROL) in the management of early stage ovarian cancer. A total of 268 eligible patients with macroscopically intrapelvic ovarian carcinoma were randomised to SL ( N =138) or CONTROL ( N =130). The primary objective was to compare the proportion of patients with retroperitoneal nodal involvement between the two groups. Median operating time was longer and more patients required blood transfusions in the SL arm than the CONTROL arm (240 vs 150 min, P <0.001, and 36 vs 22%, P =0.012, respectively). More patients in the SL group had positive nodes at histologic examination than patients on CONTROL (9 vs 22%, P =0.007). Postoperative chemotherapy was delivered in 66% and 51% of patients with negative nodes on CONTROL and SL, respectively ( P =0.03). At a median follow-up of 87.8 months, the adjusted risks for progression (hazard ratio [HR]=0.72, 95%CI=0.46–1.21, P =0.16) and death (HR=0.85, 95%CI=0.49–1.47, P =0.56) were lower, but not statistically significant, in the SL than the CONTROL arm. Five-year progression-free survival was 71.3 and 78.3% (difference=7.0%, 95% CI=–3.4–14.3%) and 5-year overall survival was 81.3 and 84.2% (difference=2.9%, 95% CI=−7.0–9.2%) respectively for CONTROL and SL. SL detects a higher proportion of patients with metastatic lymph nodes. This trial may have lacked power to exclude clinically important effects of SL on progression free and overall survival.

Background A randomized controlled trial was performed to assess the outcome of early oral postoperative feeding (EOF) compared with traditional oral feeding (TOF) in gynecologic oncology patients undergoing laparotomy with associated intestinal resection. Methods Patients aged 18–75 years, undergoing elective laparotomy, and with preoperative diagnosis of gynecologic malignancy, were eligible. Exclusion criteria included infectious conditions, intestinal obstruction, severe malnutrition, American Society of Anesthesiologists (ASA) score ≥4, and postoperative stay in the intensive care unit lasting >24 h. Patients allocated to EOF received liquid diet in the first postoperative day and then regular diet. Patients received traditional feeding scheme until resolution of postoperative ileus to start liquid diet. The primary end-point of the trial was length of hospital stay. Results Between January 1st, 2007 and March 15th, 2008, 40 patients were randomized to receive either EOF or TOF. Hospital stay in patients who received EOF ( n  = 18) was 6.9 days versus 9.1 days in the TOF group ( n  = 22) ( P  = 0.022). Requirements for analgesic and antiemetic drugs, intensity of pain, intestinal function recovery, mean levels of postoperative satisfaction, postoperative complications, and quality-of-life scores did not differ between the two groups. Conclusion Early resumption of oral intake is feasible and safe in gynecologic oncology patients undergoing intestinal resection as part of a planned surgical procedure. Moreover, significant reduction in length of hospital stay was demonstrated.

Introduction/Background*Sentinel node mapping (SNM) has replaced lymphadenectomy for staging surgery in apparent early-stage endometrial cancer (EC). Here, we evaluate the long-term survival of three different approaches of nodal assessment in low, intermediate, and high-risk EC.MethodologyThis is a multi-institutional retrospective study evaluating long-term outcomes (at least 3 years of follow-up) of EC patients having nodal assessment between 2006 and 2016. In order to reduce possible confounding factors, we applied a propensity-matched algorithm.Result(s)*Charts of 940 patients were evaluated: 174 (18.5%), 187 (19.9%), and 579 (61.6%) having SNM, SNM followed by backup lymphadenectomy and lymphadenectomy, respectively. Applying a propensity score matching algorithm (1:1:2) we selected 500 patients: 125 SNM vs. 125 SNM plus backup lymphadenectomy vs. 250 lymphadenectomy. Baseline characteristics of the study population were similar between groups. The prevalence of nodal disease was 14%, 16%, and 12% in patients having SNM, SNM followed by backup lymphadenectomy and lymphadenectomy, respectively. Overall, 19 (7.6%) patients were diagnosed with low volume nodal disease (7 and 12 patients with micrometastasis and isolated tumor cells). The mean (SD) follow-up time was 62 (±11) months. The survival analysis comparing the three techniques did not show statistical differences in terms of disease-free (p=0.750) and overall survival (p=0.899). Similarly, the type of nodal assessment did not impact survival outcomes after stratification on the basis of uterine risk factors.Conclusion*Our study highlighted that SNM provides similar long-term oncologic outcomes than lymphadenectomy. Further evidence is warranted to assess the prognostic value of low-volume disease detected by ultrastaging and the role of molecular/genomic profiling.

Introduction/Backgroundvulvar lichen sclerosus (VLS) is a chronic inflammatory dermatosis usually associated with symptoms that cause significant physical discomfort and emotional distress. The therapy of VLS is controversial, and factors that can influence the progression to neoplastic lesions are not clear.Methodologythis is a retrospective analysis of women with a diagnosis of VLS made between 2005–2010 at San Gerardo Hospital, Monza. Patients were treated with mometasone furoate 0.1% ointment for a 30-days period in association with emollient creams followed by a maintenance phase with emollient creams only at least twice a day. The efficacy of therapy was evaluated in women with at least one follow-up visit; the development of preneoplastic and neoplastic lesions was evaluated only in patients with a follow-up of at least 1 year. The association between clinical data (including demographics and response to therapy) and progression to cancer was evaluated using univariate and multivariate analysis.Resultsa total of 251 women were included in this retrospective analysis. Median age at diagnosis was 63 years. The efficacy of therapy was evaluated in 231 patients. Symptoms remission was obtained in 65% of patients, while 16% required topical steroids in addition to emollient creams in the maintenance phase. Therapy was not effective in 19% of patients. Neoplastic progression was evaluated in 144 patients. 28 women developed a vulvar carcinoma (24) or VIN (4) with a median time from VLS diagnosis of 51 months. Patients without symptoms control were significantly more likely to develop a neoplastic lesion during follow up at a multivariate analysis (p: 0.004).Conclusion symptoms remission can be obtained in the majority of patients with VLS using emollient creams only in the maintenance phase. Patients who do not respond to therapy should be carefully monitored, as they have a higher risk of developing neoplastic lesions.DisclosureNothing to disclose

Background: The role of systematic aortic and pelvic lymphadenectomy (SAPL) at second-look surgery in early stage or optimally debulked advanced ovarian cancer is unclear and never addressed by randomised studies. Methods: From January 1991 through May 2001, 308 patients with the International Federation of Gynaecology and Obstetrics stage IA–IV epithelial ovarian carcinoma were randomly assigned to undergo SAPL ( n =158) or resection of bulky nodes only ( n =150). Primary end point was overall survival (OS). Results: The median operating time, blood loss, percentage of patients requiring blood transfusions and hospital stay were higher in the SAPL than in the control arm ( P <0.001). The median number of resected nodes and the percentage of women with nodal metastases were higher in the SAPL arm as well (44% vs 8%, P <0.001 and 24.2% vs 13.3%, P :0.02). After a median follow-up of 111 months, 171 events (i.e., recurrences or deaths) were observed, and 124 patients had died. Sites of first recurrences were similar in both arms. The adjusted risk for progression and death were not statistically different (hazard ratio (HR) for progression=1.18, 95% confidence interval (CI)=0.87–1.59; P =0.29; 5-year progression-free survival (PFS)=40.9% and 53.8%; HR for death=1.04, 95% CI=0.733–1.49; P =0.81; 5-year OS=63.5% and 67.4%, in the SAPL and in the control arm, respectively). Conclusion: SAPL in second-look surgery for advanced ovarian cancer did not improve PFS and OS.

ObjectivesSentinel node mapping (SNM) has replaced lymphadenectomy for staging surgery in apparent early-stage endometrial cancer (EC). Here, we evaluate the long-term survival of three different approaches of nodal assessment in low, intermediate, and high-risk EC.MethodsThis is a multi-institutional retrospective study evaluating long-term outcomes (at least 3 years of follow-up) of EC patients having nodal assessment between 2006 and 2016. In order to reduce possible confounding factors, we applied a propensity-matched algorithm.ResultsCharts of 940 patients were evaluated: 174 (18.5%), 187 (19.9%), and 579 (61.6%) having SNM, SNM followed by backup lymphadenectomy and lymphadenectomy, respectively. Applying a propensity score matching algorithm (1:1:2) we selected 500 patients: 125 SNM vs. 125 SNM plus backup lymphadenectomy vs. 250 lymphadenectomy. Baseline characteristics of the study population were similar between groups. The prevalence of nodal disease was 14%, 16%, and 12% in patients having SNM, SNM followed by backup lymphadenectomy and lymphadenectomy, respectively. Overall, 19 (7.6%) patients were diagnosed with low volume nodal disease (7 and 12 patients with micrometastasis and isolated tumor cells). The mean (SD) follow-up time was 62 (±11) months. The survival analysis comparing the three techniques did not show statistical differences in terms of disease-free (p=0.750) and overall survival (p=0.899). Similarly, the type of nodal assessment did not impact survival outcomes after stratification on the basis of uterine risk factors.ConclusionsSNM provides similar long-term oncologic outcomes than lymphadenectomy. Further evidence is warranted to assess the prognostic value of low-volume disease detected by ultrastaging and the role of molecular/genomic profiling

Introduction/BackgroundWithin EORTC-GCCG we conducted a randomized multinational multicenter trial in order to compare the value of neoadjuvant chemotherapy followed by radical surgery with standard concomitant chemoradiation in Stage IB2-IIB cervical carcinoma. As the trial (55994) is approaching completion of its follow-up, preliminary results are presented here.MethodologyBetween May 2002 and June 2014 a total of 620 patients with FIGO stage Ib2-IIb were randomized between neoadjuvant chemotherapy followed by surgery (NACTS, arm1, N=311) with standard concomitant chemoradiotherapy (CCRT, arm2, N=309). In arm1, radical hysterectomy was required within 6 weeks after completion of cisplatin-based chemotherapy with a cumulative minimum of 225 mg/m2, in arm2, radiation consisted of 45-50Gy plus boost concurrent with weekly cisplatin chemotherapy (40 mg/m2 per week). Primary endpoint was 5-yr overall survival (OS).ResultsMedian follow-up time was 8.2 years (95%CI =7.8 yrs–8.6 yrs) and similar between both arms. A total of 191 deaths (31%) occurred. Age, stage and histological cell type were balanced in both arms. Protocol treatment was completed in 459 (74%) patients (71% for NACTS; 82% for CCRT). In arm1 238 (76%) patients underwent surgery. Main reasons for not having surgery as per protocol, were toxicity (25/74, 34%), progressive disease (18/74, 24%) and insufficient response to NACT (12/74, 16%). Additional radiotherapy was given to 113 patients (36.3%) in arm1; additional surgery performed in 9 patients (2.9%) in arm2. Short term severe adverse events (≥G3) occurred more frequently in arm1 than in arm2 (35% vs 21%, p<0.001). The 5 year OS was 72% in arm1 and 76% in arm2 (not statistically significant, difference =4.0% (95%CI: -4%–12%); HR 0.87, 95%CI: 0.65–0.15, p=0.332).ConclusionThese preliminary results revealed no difference in 5-year OS between NACTS and CCRT, indicating that quality of life and long term toxicity across prognostic factors are important to decide on optimal treatment.DisclosureNothing to disclose.

Introduction/Background*Current guidelines for surveillance strategy in cervical cancer are rigid, recommending the same strategy for all survivors. The aim of this study was to develop a robust and comprehensive model allowing for individualised surveillance strategy based on risk profile of early-stage cervical cancer patients that were referred for surgical treatment with curative intent.MethodologyThe data of 4,343 cervical cancer patients with pathologically confirmed early-stage cervical cancer treated between 2007 and 2016 were obtained from SCANN consortium centres of excellence (Surveillance in Cervical CANcer). Only patients with complete key predictor variables and a minimum of one-year follow-up data availability were included. Based on the prognostic markers, a multivariable Cox proportional hazards model predicting disease-free survival (DFS) was developed and internally validated. A risk score, derived from regression coefficients of the model, stratified the cohort into significantly distinctive risk groups. On its basis, the annual recurrence risk model (ARRM) was calculated by conditional survival analysis.Result(s)*Five variables significant in multivariable analysis of recurrence risk were included in the prognostic model: maximal pathologic tumour diameter, tumour histotype, tumour grade, the number of positive pelvic lymph nodes, and lymphovascular space invasion (table 1). The model was ten-fold internally cross-validated with the average AUC of 0.732. Five risk groups significantly differing in prognosis were identified: with five-year DFS of 97.5%, 94.7%, 85.2%, and 63.3% in consecutive increasing risk groups, while two-year DFS in the highest risk group equalled 15.4%. Based on ARRM, the annual recurrence risk in the lowest risk group was below 1% in the first year of follow-up and declined below 1% at years three, four, and >5 in the three medium-risk groups (figure 1). The proportion of pelvic recurrences declined in groups with the growing risk. In the whole cohort, 26% of recurrences appeared at the first year of the follow-up, 48% by year two, and 78% by year five.Abstract 960 Table 1Multivariate model for risk of recurrence predictionAbstract 960 Figure 1ARRM: Landmark analysis of the annual probability of recurrence after surgery. N/A not analysed.Conclusion*ARRM represents a powerful tool for tailoring the surveillance strategy in early-stage cervical cancer patients based on the patient´s risk status and respective annual recurrence risk. It can easily be utilised in routine clinical settings internationally.

Introduction/Background*The impact of lymph node (LN) micrometastases (MIC) in cervical cancer patients remains a controversial topic given their low incidence and good prognosis of patients managed by primary surgery.We aim to evaluate the prognostic significance of MIC and isolated tumour cells (ITC) in a large cohort of patients from the SCCAN retrospetive study (Surveillance in Cervical CANcer). SCCAN study analysed data from more than 4300 patients with early stage cervical cancer treated by primary surgery at 20 large tertiary institutions from Europe, North America, South America and Australia.MethodologyIn this SCCAN sub-study, we included patients with early stage cervical cancer (T1a1 LVSI+ – T2b) treated between 2007 and 2016 with at least 1-year follow-up data availability, who underwent primary surgery including sentinel lymph node (SLN) biopsy and in whom SLNs were processed by pathological ultrastaging protocol.Result(s)*Out of 969 included patients with at least 1 SLN detected, 174 (18%) had positive LN (table 1). Maximal tumour diameter >2cm, positive LVSI, grade ≥ 2, uncommon histological type (neuroendocrine, sarcoma, etc.) and macrometstasis (MAC) or MIC in LN were factors associated with significantly decreased five-years disease free survival (DFS) (table 2). MAC, MIC or ITC was the largest LN metastasis in 84 (9%), 59 (6%) and 31 (3%) cases respectively. Adjuvant (chemo)radiation was administred in 89%, 85% and 58% of patients with MAC, MIC and ITC. DFS reached 75%, 73% and 83% in patients with MAC, MIC and ITC compared with 90% in the N0 patients. Patients with MAC and MIC had significantly decreased DFS than those with N0 disease (HR=2.36 and 2.55).Abstract 898 Figure 1Abstract 898 Table 1Data summary (N = 969) Characteristics Description Tracer type Radiocolloid 423 (43.7%) Dye 662 (68.3%) ICG 220 (22.7%) No. of SLN detected Mean ± SD 3.2 ± 2.2 Largest type of metastasis in LN including SLN Negative 795 (82.0%) ITC 31 (3.2%) MIC 59 (6.1%) MAC 84 (8.7%) Surgical approach Open 575 (59.3%) Robotic 195 (20.1%) Laparoscopic 199 (21.5%) Tumour histotype Squamous 605 (62.4%) Adenocarcinoma 287 (29.6%) Adenosquamous 50 (5.2%) Neuroendocrine 18 (1.9%) Other 9 (0.9%) Grade 1 149 (15.4%) 2 406 (41.9%) 3 246 (25.4%) N/A 168 (17.3%) LVSI No 316 (32.6%) Yes 351 (36.2%) N/A 302 (31.2%) Maximal pathologic tumour diameter [mm] Mean ± SD 20.6 ± 13.7 Median (IQR) 19 (10; 30) < 0.5 cm 73 (7.5%) 0.5–1.99 cm 424 (43.8%) 2–3.99 cm 376 (38.8%) ≥ 4 cm 96 (9.9%) Adjuvant therapy 312 (32.2%) if yes: radiotherapy 153 (49.0%) chemoradiotherapy 136 (43.6%) chemotherapy 18 (5.8%) chemoradiotherapy + chemotherapy 5 (1.6%) Recurrence 117 (12.1%) Abstract 898 Table 2Univariate analysis of factors associated with disease-free survival (N = 969) Predictor Category n HR (95% CI ) p-value Surgical approach Open 575 Ref. Robotic 195 1.21 (0.74; 1.97) 0.439 Laparoscopic 141 1.51 (0.93; 2.45) 0.097 Combined 58 1.06 (0.48; 2.31) 0.888 Tumour diameter < 0.5 cm 73 Ref. 0.5–1.99 cm 424 1.67 (0.51; 5.47) 0.399 2–3.99 cm 376 3.98 (1.25 ; 12.69) 0.019 ≥ 4 cm 96 6.35 (1.91 ; 21.13) 0.003 LVSI No 316 Ref. Yes 351 2.31 (1.47 ; 3.63) < 0.001 Tumour histotype Squamous 605 Ref. Adenocarc. 287 1.13 (0.75; 1.71) 0.554 Adenosquamous 50 1.38 (0.66; 2.89) 0.385 Other 27 3.03 (1.45 ; 6.31) 0.003 Grade 1 149 Ref. 2 406 2.08 (1.02 ; 4.22) 0.044 3 246 3.35 (1.64 ; 6.85) < 0.001 Largest type of metastasis in LN Negative 795 Ref. ITC 31 1.67 (0.68; 4.14) 0.264 MIC 59 2.55 (1.47 ; 4.43) < 0.001 MAC 84 2.36 (1.44 ; 3.87) < 0.001 Largest type of metastasis in LN Negative 795 Ref. ITC 31 1.67 (0.68; 4.14) 0.264 MIC+MAC 143 2.44 (1.63 ; 3.64) < 0.001 Conclusion*Early-stage cervical cancer patients with MIC in pelvic LN have significantly decreased DFS. Their management should follow the same principles as in patients with MAC.

ObjectivesUltra-staging (US) of sentinel lymph nodes (SLN) increases the detection of nodal metastases. US protocols vary among gynecologic pathologists, and internationally accepted guidelines are still not available. This study compares two US protocols (US-A vs US-B) in early stage cervical (CC) and endometrial cancers (EC) (table 1).MethodsWe retrospectively evaluated patients with clinical stage I endometrial cancer (EC) or stage IA-IB1 cervical cancer (CC) who underwent primary surgery with SLN biopsy from November 2010 to October 2017.Results229 patients were analyzed (161 ECs and 68 CCs). The rate of positive node disease was: 22% with US-A protocol and 12% with US-B protocol (p=0.09) for EC patients; 22% and 10% (p=0.18) for CC patients. Macrometastasis, micrometastases, and ITC were 31%, 61% and 8%, respectively with US-A protocol; 43%, 40% and 17%, respectively with US-B protocol (p=0.272). Mean size of nodal metastasis was 5.4±6.3 mm for US-A and 3.2±4.3 mm for US-B protocol (p=0.09). On multivariate analysis including grade and LVSI, the US method was not associated with the detection of nodal metastases.ConclusionsApproximately 50% of the nodal metastases detected by US of SLNs were low-volume metastases. In this study, the detection of positive node disease was not associated with the type of US protocol used. Larger multicenter prospective studies are advisable to confirm these results.